AccessClosure: FDA Clearance--Yes; Product Launch--Not Yet
Sometimes just getting FDA approval isn't enough. AccessClosure got FDA clearance of its PMA vascular closure device, only to delay the product's launch in order to develop an improved version. The company forestalled one-and-a-half years of revenue to address physicians' concerns and introduce an improved product. This was particularly wise in the field of vascular access closure devices, where previous devices have disappointed. The decision appears to be paying off as the company is seeing rapid adoption even though its product is priced at a premium.
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In Vivo interviews device entrepreneur Amar Sawhney whose engineering background led him to Focal Inc. There Sawhney advanced important developments in sealant technology that eventually formed the basis of Confluent Surgical, the first company launched by Incept, Sawhney and fellow entrepreneur's Fred Khosravi's device incubator.
Located on opposite coasts and with complementary skill sets, Fred Khosravi, founder of EndoTex, teamed up with Amar Sawhney, founder of Confluent Surgical, to form Incept, which has become a powerful device company creation engine. Using a unique formula that launches new companies building on previous successes, Incept has compiled an enviable record, starting nine companies in 11 years with three exits and no failures.
Despite the best intentions and brightest innovation, start-ups haven't been able to tap into the huge potential presented by the vascular closure market. Ten years after the first generation devices made it to market, the original two leaders still dominate despite the limitations of their devices, while many start-ups have come and gone. A long list of new hopefuls believe they have the solution physicians have desired. Now all they have to do is convince the physicians, who, when it comes to vascular closure devices, are slow to recognize clinical data but quick to embrace a device that feels right to them.